Cook Medical recalls all 4m Beacon Tip catheters

The catheter recall that’s been bedeviling Cook Medical since last year grew last month as the company recalled all lots of catheters using its Beacon Tip locating technology.

The move stems from an increase in reports that the polymer used in the tips degrades over time, causing the tips to fracture or separate during procedures. Cook Medical said it’s received 30 reports of tip splitting to date.

The Bloomington, Ind.-based medical device giant recalled its 1st batch of Beacon Tip-equipped angiography catheters in August 2015, but the action quickly expanded to include other devices equipped with the locating technology. Cook Medical said the problem might have to do with a sterilization process.

“Our preliminary investigation into this matter has identified that environmental conditions, such as storage temperature, humidity, and the use of Vaporized Hydrogen Peroxide (VHP) for whole-room decontamination within healthcare facilities, may be contributing to the occurrence,” the company wrote in an April 21 letter advising customers of its latest catheter recall. “We also recognize that there may be other undetermined contributors to this issue and continue to investigate.”

The full list of recalled catheters can be found here.

Cook said potential adverse events could include device fragments in the vasculature, possibly leading to cardiac or pulmonary embolization or end-organ occlusion. The problem could also leave fragments in the genitourinary system or other soft tissues, the company said.

At least 1 of Cook Medical’s rivals is looking to capitalize on the recall. Merit Medical (NSDQ:MMSI) chief Fred Lampropoulos said last week that his company is ready to take advantage.

“In the 35 years I have been in the industry, I have never seen anything like this. It’s so unfortunate for a great company,” Lampropoulos saud during a conference call with analysts discussing Merit’s 1st-quarter results. “It’s going to be, I think, a long time. Once you start pulling product you have to get it, of course, re-qualified. I do not want to speak on behalf of Cook, nor would be appropriate, but it’s going to be long and it’s going to be deep and it’s going to create a great opportunity for Merit.”

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